510(k) · Cleared
ClearedINFINITY OCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKG Posterior Cervical Screw System
Cleared on Jan 11, 2023 as substantially equivalent to K163375 (Medtronic Sofamor Danek USA, Inc., 2017) and 1 other predicate after a 27-day review. Its family tree reaches back 16 generations to 2004.
- Decided
- Jan 11, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K040583 (2004). 137 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- This deviceK223764 INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc. · 2023
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 3 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- This deviceK223764 INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| −3 | K152457 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −1 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| 0 (this device) | K223764 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 25 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163375 | INFINITY™ OCT SystemSummary page 5…Classification: Class II Product Code: NKG, KWP III. Predicate Devices: INFINITYTM OCT System (K163375, Primary Predicate S.E. 08/21/2017)… | 2017 |
| * | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 5…Vertex® Reconstruction System Additional Predicate (K090714, S.E. 04/17/2009) IV. Device Description: The INFINITYTM OCT System is a posterior occipitocervical-upper thoracic… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 15 of the 137 ancestors have a recall of any class.
- 6 other devices also cite its predicate K163375.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The INFINITY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: • Traumatic spinal fractures and/or traumatic dislocations. • Instability or deformity. • Failed previous fusions (e.g. pseudarthrosis). • Tumors involving the cervical spine. •…
Read the full statement (288 words)
The INFINITY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223764: INFINITY OCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223764
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026